ONE Health Live
Examining the issues of importance to animals, humans and the environment to help those across the food production system better understand the issues from a science-based perspective.
ONE Health Live
From lab to label: The decade-long journey of animal health products
Have you ever wondered why it takes so long to bring a new animal health product to market? Dr. Ron Tessman, Beef Cattle Technical Consultant with Elanco Animal Health, pulls back the curtain on the extensive research and development process that ensures the medications your livestock receive are both safe and effective.
What appears on the surface as a straightforward product development cycle actually represents an intensive scientific journey spanning over a decade. Dr. Tessman reveals that while the industry standard suggests 8-10 years for FDA-regulated food animal products, his personal experience shows most take 12+ years before reaching producers. This timeline reflects the meticulous process of screening countless potential compounds for safety and efficacy before narrowing down to those worthy of further development.
The regulatory approval process encompasses multiple parallel workstreams, including target animal safety, effectiveness studies, manufacturing controls, and increasingly important environmental assessments. For food animal products, human food safety considerations add additional layers of scrutiny through residue chemistry, toxicology assessment, and antimicrobial resistance evaluation. Dr. Tessman emphasizes that these regulations aren't simply bureaucratic hurdles but essential safeguards protecting our food supply and ensuring producers receive consistent, dependable products. Unlike many approval processes, animal health products require submission of all raw study data for FDA review, creating unparalleled transparency and thoroughness.
Join us for this exploration of how animal health companies like Elanco navigate complex development pathways while addressing emerging resistance concerns and meeting evolving sustainability expectations. Whether you're a producer, veterinarian, or simply curious about food safety, this episode offers valuable insights into the science behind the products that protect animal health and our food supply. Subscribe to One Health Live for more thought-provoking conversations at the intersection of animal, human, and environmental health.
Welcome to One Health Live, where we examine the topics of importance to animals, humans and the environment. Our goal is to help those across the food production system better understand the issues at hand from a science-based perspective. Better understand the issues at hand from a science-based perspective. In One Health Live, we strive to be thought-provoking and fact-based, as we bring you the latest in news and insight. This episode of One Health Live is brought to you by Elanco Animal Health, a global leader dedicated to improving the health of beef cattle by supporting the prevention, control and treatment of disease. I'm Ann Hess, and with me today to dig into research and development product development is Dr Ron Tessman, beef Cattle Technical Consultant with Elanco Animal Health. Welcome, dr Tessman, and thank you for joining us today.
Speaker 2:Well, thank you for having me, Ann. I'm very happy to be here to discuss this topic.
Speaker 1:So let's kick off our conversation here by discussing how long it takes to bring a new animal health product to market. We always hear it can be quite lengthy and stringent in terms of the data requirements. What's involved in the process?
Speaker 2:Yeah, that's a very good question. One thing I'd like to level set is that we'll be talking about products pharmaceutical products that we develop through the FDA, realizing that in the US there's actually three different regulatory bodies that are responsible for animal health products, depending upon what they are. So the EPA does insecticides and the USDA is in charge of vaccines or biologicals. But we'll focus today on the FDA products. That's what I'm most associated with, although I have worked on some other products through the development and approval process, and what we say usually from an industry perspective for a food animal product is eight to 10 years. That's kind of the baseline that we use. However, in my experience, I've been fortunate enough to be involved with a number of products that have actually made it to market through the development process, and I haven't been involved with one that took less than 12 years. So, yeah, it can take quite a long time.
Speaker 1:So I know there's quite a few regulatory hurdles to clear here. Tell us about that research and that development process at Elanco, knowing how this process works, how you narrow it down and decide what products are needed in the market.
Speaker 2:Yeah, so when we think about what we are going to pursue, what sort of products that we want to develop, we look around to see what issues there are in the market, whether that be, you know, up and coming diseases, indications, or whether that's something that actually we're hearing from producers, hearing from the marketplace, that these are things that they're struggling with and that they need, and so it's kind of a combination of those things. We also work fairly closely with different universities and look to see what they're working on, what sort of research they're doing, and then from there just think of it as a big funnel. So, whether it's a particular indication or a number of projects, you can think of either way on those things, but you have lots of different. So let's say, for instance, an antibiotic for treatment of bovine respiratory disease, you have a lot of potential active ingredients that you could use and we generally separate it from the research to the development stages. They're kind of two different and on the research side you have a lot of different potential active ingredients that you do basic research on looking at. You know laboratory effectiveness, you look at safety. That's very important. Those are the two number one things, right, efficacy and safety.
Speaker 2:We want to make sure we have a safe compound that we can use and also one that's going to translate to effective product. We screen those for a number of different studies and different manners no-transcript. And then from there those candidates we look at, you know, look at some service formulations and do some more really targeted animal testing. You know, in the target, several years in and of itself, to just kind of narrow that thing down and get to that, to that one formulation, and then we can develop the go into the development process, the actual real process, where we're interacting quite a bit with the FDA, the Center for Veterinary Medicine. You know, often we say CVM, cvm, fda. It's the same thing. It's the part that is the part of the FDA that's responsible for animal health products and there's a lot of different parts within that that we have to, different parts within that that we have to meet and get approval processes through and those can be broadly broken up into target animal safety. So safety in that target animal, that target species effectiveness Do we show effectiveness against the particular disease process that we're trying to get this approved for Chemistry manufacturing and control.
Speaker 2:So that's CMC, that's really the manufacturing of the product and that really is important because can we make the product, can we consistently make the product, and can the producer be be assured, the producer of the veterinary be assured that every bottle is going to be the same. You know, from year to year, from lot to lot, that I'm getting the same product. It's safe. You know, in the case of a sterile injectable, it's sterile. I'm not going to have some.
Speaker 2:You know something that's, you know, gone awry in that process, and so that in and of itself is a big challenge. And then, something that really has been emphasized it's always been part of it but has received a lot of emphasis over the last several years is the environmental assessment, environmental impact. What really, you know, are these products doing to the environment? You know, after we, you know, give them to the animal, they're safe and effective, but you know there's going to be some parts of that product or breakdown that go into the environment, and so we're very concerned the FDA is, but we are as well. You know, what is that doing to the environment? Is there any off-target species of animals of? You know, bacteria, you know any sort of organisms that we might be adversely affecting, that we really don't want to affect? And so that's a very important part in getting a lot more emphasis over the last few years.
Speaker 2:And then the human food safety, and that's a huge part of a food animal data package and something that differs from a companion animal product, right, because we're, ultimately, we're trying to produce, you know, protein food for humans and we want to make sure that we have a safe product for you know people to eat afterwards or for people to consume, and that can be broken down into a couple of different areas as well. In the human food safety, there's, you know, the residue chemistry part, and when we think of residues, think of withdrawals, right, so we apply the product to the animal you know, whether, know, whether you know it'd be a sterile injectable or something that we apply on the back of the animal or orally, and we need to know how long that compound is going to last in the, in the, in the animal, because we don't want, you know, humans to be, you know, taking that in as well, and so that's a very important part, something that is, uh, that takes some time. Um, we have to go to some specialty places to have some of those, some of that parts of that uh completed. Um, and then the toxicology assessment. So aside from the safety, there's also toxicology are. Are there things happening that you know if a person should, you know, get, should get even minuscule amounts having untoward effects in that person, and we don't want that and we've seen over the years where certain chemicals, certain products have been removed because of potential effects that those could have on humans. So very important part of what we do.
Speaker 2:And then, in the case of an antibiotic, one of the things that we talk about on the human food safety is whether or not we're having an adverse effect on those organisms that are in the feces that might actually contaminate, so like E coli, salmonella, that could contaminate meat. You know that doesn't happen very often. Thankfully we have a very good system in the US for that. The FSIS does a great job of monitoring those things in our production. But it could happen. But we don't want to create an issue in those organisms that could also cause problems in humans, and that's something that's a big part of our development process as well. And so you have all of these different streams working somewhat in parallel. We don't have to do them necessarily in a stepwise fashion. If we did, it would take 20 years.
Speaker 1:Yeah, yeah, a lot of boxes to tick off there to get a product to market, and even you know some of some of these things. Like you mentioned, sustainability are really becoming quite an issue for people and they and they want to know some of these answers before it hits the shelves. So, as you're addressing these producer challenges, how important is it to find new modes of action? And what about resistance development, and can that play into potential active ingredients and product formulations you choose for research and development?
Speaker 2:Absolutely. That's always something that we consider, especially if we're thinking about something, you know, a disease challenge that's been around for a long time. So if we think about internal parasites, that's something that we continually have to work with. Or the bacteria that cause respiratory disease in cattle, and so when we're considering what active ingredient that we're going to use in our products, we really want to look to see, okay, does this actually do something additional that isn't already available, that isn't already out there? So, you know, does it fit a place where there is maybe some resistance development and we don't have? You know, there there's been no exposure and so we don't have that resistance development.
Speaker 2:Or alternatively, it's amazing that you know a lot of these new chemical entities that get tested. You test them and because you know biology is biology, there's already some pre-existing. You know tolerance or resistance to that active ingredient already that just exists in the naturally, in the population of the bacteria or the organisms that we're trying to treat, and so that would be something that we wouldn't go down the path. And then you know, when we think about developing not only the formulation, so how we administer it to best get it there and to hopefully prevent resistance development in that formulation, how that active ingredient is going to interact with that formulation and then give us the results in the animal. We also think about how best should we develop the treatment regimen. You know, how should this be used in order to try and prevent resistance from development in those animals once it gets on the market?
Speaker 2:So all those things are very important when we think about how we're going to develop a product. And they'll take whole projects off right. If we get down a certain path and we see, hey look, this just isn't going to fit, you know it's not going to be viable for an extended period of time, we'll just take that off off the list. And that's why, you know, I always like to think of a big funnel, because things start out, you've got a lot of good ideas and then you slowly, slowly try and narrow it down to the things that are going to be the most safe and effective and really fit that need out in the market.
Speaker 1:Dr Tesma, as we finish up our conversation here today, any key takeaways you'd like to leave our audience?
Speaker 2:One of the things that you know I'm that I'd really like to emphasize is that you know regulatory bodies and regulations have gotten kind of a bad rap over the last few years and in some ways it's really true when you look. But I really look at the regulations and the things that we have to meet for the FDA as very positive. It keeps our food supply safe, it keeps our producers safe and makes you know and sets a high bar to make sure that we're producing safe and effective products that people can depend on. So I think that's one important thing.
Speaker 2:The other really important thing that I think that people should realize is that you know, in the animal side of approval, we have to submit every piece of raw data that goes into our studies, and so everything, everything that we write down, every observation, whatever it may be down, every observation, whatever it may be, actually gets reviewed by the agency. Now that does extend the time right for approval, so that's one of the reasons why the timeline can be fairly long, but it also ensures that we're not missing anything, at least with regard to those animals that we're studying for approval.
Speaker 1:So you know, people can be assured that we're producing safe and effective products. I'm Anne Hess and you've been listening to One Health Live. If you would like to hear more conversations on the issues of importance to animals, humans and the environment, subscribe to this podcast on your favorite podcast channel. Until next time, have a great day and thanks for listening.